COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Preoperative Levosimendan and Heart Failure (PELS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01022983
Recruitment Status : Withdrawn (Not finding patients for including)
First Posted : December 1, 2009
Last Update Posted : December 17, 2012
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Espen Lindholm, Sykehuset i Vestfold HF

Brief Summary:
The purpose of this study is to investigate the safety and efficacy of Levosimendan given preoperative to patients with heart failure undergoing noncardiac surgery.

Condition or disease Intervention/treatment Phase
Heart Failure Hip Fracture Drug: Levosimendan Drug: Placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preoperative Levosimendan in Patients With Heart Failure Undergoing Elective Noncardiac Surgery: A Randomized, Placebocontrolled Trial. SIMPLE Study
Study Start Date : April 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Levosimendan Drug: Levosimendan
At least 2 hours before surgery: Infusion of Levosimendan (0,1 microgram/kg/min.). 24 hours of infusion without a bolus.
Other Names:
  • Simdax
  • ATC-nr.: C01C X08

Placebo Comparator: Povidon, waterfree etanol, glucosis 5% Drug: Levosimendan
At least 2 hours before surgery: Infusion of Levosimendan (0,1 microgram/kg/min.). 24 hours of infusion without a bolus.
Other Names:
  • Simdax
  • ATC-nr.: C01C X08

Drug: Placebo
ml/kg/hours - same infusion rate as active comparator

Primary Outcome Measures :
  1. Heartfailure - Highest NT-proBNP-value the first 7 days after surgery [ Time Frame: NT-proBNP 6 hours postoperative, 24 hours postoperative, 48 h postoperative, 72 h postoperative, 96 h postoperative, 120 h postoperative, 144 h postoperative and 168 h postoperative ]

Secondary Outcome Measures :
  1. Days of hospitalization [ Time Frame: Hospital stay - number of days patients are hospitalized ]
  2. Use of inotropes (dopamine, Norepinephrine)during postoperative unit stay. Mg/microgram [ Time Frame: After 16-18 hours, after 48 hours and every 24 hours if still in the PO-Unit ]
  3. Mortality [ Time Frame: 30 days ]
    Visits or patients record

  4. Ischemia [ Time Frame: 7 days postoperative ]
    Continous ECG first 24 hours an ECG every second day

  5. Myocardial necrosis [ Time Frame: 7 days postoperative ]
    Troponin taken every day postoperative

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute surgery. Hip Fracture
  • Patient with cardiac failure (EF < 35%) or known coronary disease
  • At least 2 of 11 comorbidities
  • Patient has to use at least one heart failure medication
  • Symptoms of heart failure
  • NT-proBNP > 2000pg/ml

Exclusion Criteria:

  • < 18 years old
  • Participants in other pharmacological study
  • Abuse of medicaments or alcohol
  • Pregnant or breastfeeding women
  • AMI at admission
  • HOCM
  • Serious aortic stenosis (< 1 cm2)
  • Sustained ventricular tachycardia
  • Earlier episodes of "torsades de pointes"
  • Sustained heartbeat > 120/minute
  • Systolic BP < 90 mmHg
  • Surgery planned not before 2 hours of study medication can be infused preoperative
  • Cardiac surgery
  • Dementia
  • S-K < 3 mmol/l
  • Allergy levosimendan
  • Serious liver failure (Known Class C Child-Pugh score)
  • Serious kidney failure (GFR < 30 ml/min.)
  • Prolonged QTc-interval (male QTc > 0,43 s, female QTc > 0,45 s)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01022983

Layout table for location information
Oslo University Hospital - Ullevål
Oslo, Norway
Vestfold Hospital Trust
Tonsberg, Norway, 3103
Mölndal Hospital
Gothenburg, Sweden
Universitety Hospital Örebro
Hudiksvall, Sweden
Sponsors and Collaborators
Sykehuset i Vestfold HF
Orion Corporation, Orion Pharma
Layout table for investigator information
Study Director: Espen Lindholm, MD Vestfold Hospital trust, Norway
Principal Investigator: Knut A Kirkebøen, PhD Oslo University Hospital - Ullevål, Norway
Principal Investigator: Mathias Kotyra, Md Mölndal hospital, Sweden
Principal Investigator: Anders Nydahl, Phd University Hospital Örebro, Sweden

Layout table for additonal information
Responsible Party: Espen Lindholm, Seksjonsoverlege, Sykehuset i Vestfold HF Identifier: NCT01022983    
Other Study ID Numbers: SIMPLE
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Hip Fractures
Heart Diseases
Cardiovascular Diseases
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Cardiotonic Agents
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs